MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION DEVICE

Model Number 20300101

Device Problems Device Stops Intermittently (1599); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the nanoknife system (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation.To date, the generator has yet to be returned.Attempts are being made to obtain the unit.An investigation into the root cause for the event is currently in process.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The results of the unit evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported (b)(6) 2016, a (b)(6) male patient presented for an ire (irreversible electroporation) procedure of the pancreas.During the procedure, the nanoknife system unexpectedly shut down approximately 5 times.The first time was after 2 high currents during a 6 probe ire.The additional 4 shut downs occurred without a high current approximately 5 - 15 minutes in sequence.Each time, the unit was restarted and the procedure was resumed.As there was a delay in the procedure due to the unit malfunction, it is assumed the patient was under anesthesia for an extended time.It was reported that the patient suffered no adverse effects due to the event.It was reported the nanoknife system is available for return to the manufacturer for evaluation.

Manufacturer Narrative

The nanoknife generator (sn (b)(4)) was returned for evaluation and repair.The unit was received in good condition.During assessment the generator was tested at multiple settings per hardware unit testing procedures and the unit did not shut down as reported.The unit functioned as intended and the reported failure could not be replicated.The unit was tested per manufacturing operational verification procedure and met all acceptance criteria.The customer's reported complaint description of the unit shutting down and delay in procedure is confirmed based on information provided by the treating physician, however the failure could not be replicated during testing of the generator.The root cause for the failure could not be determined as no defects were found with the generator during testing.The user manual (nanoknife user manual, 160-105261 rev 01 version 2.2.1), instructs the user to reboot the system to let the auto-test check the system.Repeat any portions of ablation that were not delivered.A review of the lot history records for the disposable nanoknife probe associated with the event was performed for the packaging lot (151008) for catalog number 20400101 obtained through a ship history report for any deviations related to the reported defect of the complaint.The review confirms that the packaging lots and all component lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 5573396
• MDR Text Key: 42524159
• Report Number: 1319211-2016-00055
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR